Cleared Traditional

LIPASE REAGENT SYSTEM

K940457 · Medical Diagnostic Technologies, Inc. · Chemistry
Jun 1994
Decision
121d
Days
Class 1
Risk

About This 510(k) Submission

K940457 is an FDA 510(k) clearance for the LIPASE REAGENT SYSTEM, a Olive Oil Emulsion (turbidimetric), Lipase (Class I — General Controls, product code CET), submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on June 2, 1994, 121 days after receiving the submission on February 1, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1465.

Submission Details

510(k) Number K940457 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1994
Decision Date June 02, 1994
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CET — Olive Oil Emulsion (turbidimetric), Lipase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1465

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